federal_register: 2025-23413
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025-23413 | Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits | Rule | The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the electrical tongue nerve stimulator to treat motor deficits. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens. | 2025-12-19 | 2025 | 12 | https://www.federalregister.gov/documents/2025/12/19/2025-23413/medical-devices-neurological-devices-classification-of-the-electrical-tongue-nerve-stimulator-to | https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23413.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, the Agency, or we) is classifying the electrical tongue nerve stimulator to treat motor deficits into class II (special controls). The special controls that apply to the device type are identified in this order... |